A Feasibility Device Study to Prevent Female Urinary Stress Incontinence

January 4, 2018 updated by: Watkins Conti Products. Inc.

Randomized, Crossover Feasibility Study of a Device to Prevent Female Urinary Stress Incontinence

This study will test the acute efficacy of an investigational device (Yoni.Fit) in a clinical trial of women with incontinence in a standardized set of challenges performed with and without the device in place.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Potential subjects will be pre-qualified by a 6-item questionnaire, the validated Questionnaire for Urinary Incontinence Diagnosis (QUID). This questionnaire has 3 questions each referring to the seriousness of Stress Urinary Incontinence (SUI) and of Urge Urinary Incontinence (UUI). Subjects will be accepted if their SUI score is 5 or greater and is greater than the UUI score. For privacy reasons, these scores will not be retained. Subjects will then be given an appointment. Subjects will be instructed to wear comfortable athletic type wear and not to drink any fluid for two hours prior to their appointment.
  2. When subjects appear for their appointment, subjects will be administered the informed consent by the Study Coordinator. All paperwork will be pre-numbered with a code that will link to the subject name. The key will be kept confidential by the Study Coordinator. They will be instructed to empty their bladders and will be given a liter of water or other drink and instructed to drink it over a 15-20 minute time period. An abbreviated patient history will be obtained for the purpose of establishing whether the subject meets the inclusion criteria and is not disqualified by meeting the exclusion criteria. The subject will again fill out the QUID questionnaire. The inclusion criteria are a SUI score of 5 or greater, predominately SUI (SUI score>UUI score) and age between 25 and 65. Exclusion criteria are predominantly UUI, prolapse greater than mild, hysterectomy or other pelvic floor surgery other than a Caesarian section, diabetes, pregnant, BMI>35 or unable to perform ten "jumping jack" exercises. Patients will be administered three additional questionnaires in order to compute a Severity Score. These questionnaires are the Urinary Distress Inventory (UDI), Urinary Impact Questionnaire (UIQ) and the Incontinence Severity Index (ISI). The scores will be multiplied together to provide the Severity Score.

  3. Patients will be randomized to Group A or Group B to participate in an abbreviated Pad Test. Group A will perform the test with the Yoni.Fit device in place then repeat the test without the device. Group B will perform the test without the Yoni.Fit device in place then repeat the test with the device in place. This test has been validated (5). An hour after finishing the liter of liquid, the subject is given a tared incontinence pad, which is then put in place. She then engages in the following mild exercise challenges..

    1. Stand from sitting 10 times.
    2. Cough vigorously while standing.
    3. Bend down to pick up small object.
    4. Perform ten jumping jacks. The subject then will remove pad, place into bag and seal. The Experimenter will then weigh pad. The subjects will be randomized so that half will perform the Abbreviated Pad Test with the Yoni.Fit device in place followed by repeating without the device in place. The other half will perform the challenges in the reverse order.
  4. The experimenter will calculate a change in score, which is the weight of the pad worn without the device in place minus the tare weight of the pad divided by the weight of the pad with the device in place minus the tare weight of the pad. In case no urine is released with the device in place, the Improvement Score will be defined as "1000". A Release Change will also be calculated as the net weight without the device in place minus the weight with the device in place divided by the net weight released without the device in place.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Urinary Incontinence Diagnosis (QUID). This questionnaire has 3 questions each referring to the seriousness of Stress Urinary Incontinence (SUI) and of Urge Urinary Incontinence (UUI). Subjects will be accepted if their SUI score is 5 or greater and is greater than the UUI score.

Exclusion Criteria:

  • Refusal to sign the informed consent document
  • SUI score is less than 5 or is less than the UUI score.
  • Predominantly UUI
  • Prolapse greater than mild
  • Hysterectomy or other pelvic floor surgery other than a Caesarian section
  • Diabetes,
  • Pregnant,
  • BMI>35 or unable to perform ten "jumping jack" exercises.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With Yoni.Fit
Subjects will perform the Abbreviated Pad Test with the Yoni.Fit first, then without the Yoni.Fit.
Device: With Yoni.Fit
Abbreviated Pad Test with Yoni.Fit first, then without Yoni.Fit.
Experimental: Without Yoni.Fit
Subjects will perform the Abbreviated Pad Test without the Yoni.Fit first, then with the Yoni.Fit.
Device: Without Yoni.Fit
Abbreviated Pad Test without Yoni.Fit, then with Yoni.Fit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pad Weight Difference
Time Frame: An hour after finishing a liter of liquid
Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.
An hour after finishing a liter of liquid

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watkins Conti Products. Inc.

Collaborators

University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2017

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

May 3, 2017

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCP001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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